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Recruiting NCT05933161

A Study of Glycemic Control in Left Ventricular Assist

Conditions: Type 2 Diabetes Mellitus Hyperglycemia Hypoglycemia

Sponsor: Mayo Clinic

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Overview
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.
Who can participate
Inclusion Criteria: * Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010 * Diagnosis of type II diabetes mellitus * Any antihyperglycemic regimen * Greater than 3 months out from LVAD implantation * Capable of utilizing smartphone device for LibreLink app for uploading glycemic data * Patients may be enrolled who have preexisting CGM in place. Exclusion Criteria: * Type I diabetics * Unable to return at 3 month evaluation * Unwillingness to participate
Interventions
Freestyle Libre 3 Continuous Glucose Monitor (CGM)
DEVICE
Locations 1
United States (1)
Mayo Clinic in Rochester
Rochester , Minnesota
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.11.2023
Completion date
01.07.2026
Registry ID
NCT05933161
Source
clinicaltrials.gov
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